What is the frequency requirement for media-fill testing for low-risk or medium-risk preparations?

The frequency requirement for media-fill testing for low-risk and medium-risk preparations is set to be annual. This means that compounding pharmacies must conduct media-fill tests once a year to demonstrate their aseptic techniques and ensure that their processes are capable of producing sterile preparations without contamination. This annual testing is crucial as it helps in maintaining the quality and safety of compounded sterile preparations.

Low-risk preparations, which involve minimal handling of sterile products, and medium-risk preparations, which may involve more complex manipulations, both require regular assessments to ensure that any potential for microbial contamination is monitored and mitigated effectively. Annual media-fill testing aligns with the regulations and standards set forth by the United States Pharmacopeia (USP) and other governing bodies, ensuring that the compounded products maintain a high level of sterility and safety for patients.

The other options reflect different frequencies that would not be appropriate for maintaining the required standards for low and medium-risk sterile compounding.